DynaMed Systems LLC

		DynaMed Systems, LLC is the developer and manufacturer of medical devices to promote the regeneration and recovery of damage to the central nervous system, the peripheral nervous system and other soft tissues such as tendons, ligaments and skin. DynaMed Systems holds the patents for the revolutionary Traxon^® Spinal Cord Repair Stimulation System, a surgically implanted (intravertevrally) electric device designed to promote the repair and recovery of the damaged spinal cord. The first human clinical trial for the Traxon^® device was successfully conducted in the United Kingdom at Leeds General Infirmary under the leadership of Neurosurgeon Jake Timothy in 2007. Rigorous animal trials by DynaMed Systems' researchers and trials at independent laboratories have shown the Traxon's^® ability to repair the damaged spinal cord resulting in effective restoration of movement, sensation and bladder control in experimentally and clinically paralyzed animals. DynaMed Systems' technologies apply oriented and linear electromagnetic fields to damaged nerve fibers or other tissues. Under the influence of properly directed fields, cells grow in an organized fashion and migrate faster into damaged areas. This results in more rapid and effective healing than would otherwise occur. DynaMed Systems has developed a number of additional revolutionary devices that are either surgically implanted or topically applied, which are at various stages of development. Each device uses a low energy electric field, which is applied in a specific orientation, strength and duration to promote the recovery and healing of damaged nerves and soft tissues.

		The FDA has approved the device to be tested in a clinical trial in the United States. The Traxon^® Spinal Cord Repair Stimulator System is a sugically implanted intravertebral electronic device for treating acute spinal cord injury. This first clinical trial (known as a "pilot study") will test the ability of the device to safely regenerate the human spinal cord and restore function to damaged nerves. The pilot study will include patients between the ages of 18 and 73 who have suffered a recent spinal cord injury and have no voluntary motor activity or sensory function below the injury point. In each of the patients studied, implantation must take place not longer than 4 weeks after the injury. The surgery requires approximately 90 minutes. The study, which includes extensive physical, neurological, laboratory and x-ray examinations to determine the safety of the device and potential effectiveness for helping patients recover function, will be a maximum of 26 weeks. During that time, patients will also receive the standard medical care and follow-up for spinal cord injury. Details of the clinical trial will be announced shortly on this website. For further information please contact us directly.

		The device consists of one pair of electrodes and a stimulator unit (pacemaker-like power pack). The electrodes are implanted intravertebrally (inside the spinal column), as close to the spinal cord injury site as possible without touching the cord. The power pack is implanted away from the electrodes in a fleshy pocket near the patient's waist. The implanted electrodes direct a small electric field across the injured spinal cord and not the surrounding bone or muscle tissue. The medical team will remove the device upon completion of therapy (within 26 weeks). DynaMed Systems' Traxon^® device was specifically designed for intravertebral implantation. This placement will assure maximum regeneration as well as maximum safety to the spinal cord and surrounding tissues.

		Business Wire Press Release 4/28/08
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